510(k) Report

Devices descending from K955612

1,548 later devices reach RD-1200H Normal Mode Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K052336Spectraquattro Pulsed Light SystemAmjet Distribution, LLC20050—
+5K051508Med Flash II Intense Pulsed Light System.General Project S.R.L.20058—
+5K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+5K050841Fraxel SR Laser SystemReliant Technologies, Inc.2005238—
+5K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+5K041554Aip Intense Pulsed Light SystemAesthera Corporation20059—
+5K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc.2005109—
+5K043329Omnilux Revive and BluePhoto Therapeutics Limited2005202—
+5K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+5K050218Wavelight SinonWavelight Laser Technologie AG20050—
+5K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+5K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc.2005365—
+5K043319Clareon and Solarus Pulsed Light Devices and AccessoriesNovalis Medical, LLC200415—
+5K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+5K041969Aurora DSSyneron Medical, Ltd.2004302—
+5K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+5K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+5K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc200411—
+5K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+5K040156Ifl Professional System, Model C100Cyden Limited20040—
+5K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+5K032191Omnilight Fluorescent Pulsed Light SystemLuxsano AB20039—
+5K031489PitangaSyneron Medical, Ltd.20030—
+5K031988Aurora DSSyneron Medical, Ltd.2003450—
+5K030426Omnilux RedPhoto Therapeutics Limited2003563—
+5K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd.20037561
+5K024259Pulsed Light Therapy System, Model# UV-300New Star Lasers, Inc.20030—
+5K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd.2003756—
+5K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis2003856—
+5K030480L600 Hair RemovalA&M Technology20031—
+5K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+5K024064Polaris DSSyneron Medical, Ltd.2003681—
+5K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+5K022607SpectrapulsePrimary Technology, LLC20020—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K251398IPL Hair Removal Device (IPL-001, IPL-002)Shenzhen Enmind Technology Co., Ltd.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.20250—
+6K250942Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR…Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250938Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250384IPL400El Global Trade, Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241998Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S…Shenzhen Ulike Smart Electronics Co., Ltd.20246—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+6K230362Planar LED mateShenzhen Leaflife Technology Co., Ltd.20230—
+6K230025IVYLASER Handhold Hair Removal MachineIvylaser (Beijing) Technology Co.,Ltd20230—
+6K230090Diode Laser Hair RemovalWuhan Lotuxs Technology Co., Ltd.20230—
+6K22079410PLTentech Co., Ltd.20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K220103LED Therapy Device (Planar LED/Planar LED mini)Shenzhen Leaflife Technology Co., Ltd.20221—
+6K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K211368IPL Hair Remover, Model: G993, G996, G998 and G885Shenzhen Mywin Technology Co., Ltd.20211—
+6K212099Red Wave Hair RemovalShenzhen Accompany Technology Co., Ltd.20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K192621Medical RFTriworks Group Srl20200—
+6K200616E>EyeCE-Swin20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193656SkyPulseFotona D.O.O.202011—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K191086ExciplexClarteis20194—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd.201922—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181734Beurer IPL 8500 device/ IPL VelvetSkin ProHome Well Trading, Ltd.20181—
+6K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—